JP2022514835A - インスリン及びグルカゴンを含む薬学組成物 - Google Patents

インスリン及びグルカゴンを含む薬学組成物 Download PDF

Info

Publication number
JP2022514835A
JP2022514835A JP2021534266A JP2021534266A JP2022514835A JP 2022514835 A JP2022514835 A JP 2022514835A JP 2021534266 A JP2021534266 A JP 2021534266A JP 2021534266 A JP2021534266 A JP 2021534266A JP 2022514835 A JP2022514835 A JP 2022514835A
Authority
JP
Japan
Prior art keywords
cysteine
insulin
amino acid
acid
glucagon
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2021534266A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022514835A5 (https=
Inventor
ジョンクク キム
ジョンスク リー
ジョヨン ドン
エイ ラム リー
Original Assignee
ハンミ ファーマシューティカル カンパニー リミテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ハンミ ファーマシューティカル カンパニー リミテッド filed Critical ハンミ ファーマシューティカル カンパニー リミテッド
Publication of JP2022514835A publication Critical patent/JP2022514835A/ja
Publication of JP2022514835A5 publication Critical patent/JP2022514835A5/ja
Priority to JP2024147410A priority Critical patent/JP2024178193A/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2021534266A 2018-12-21 2019-12-23 インスリン及びグルカゴンを含む薬学組成物 Pending JP2022514835A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024147410A JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2018-0167798 2018-12-21
KR20180167798 2018-12-21
PCT/KR2019/018320 WO2020130751A1 (ko) 2018-12-21 2019-12-23 인슐린 및 글루카곤을 포함하는 약학 조성물

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024147410A Division JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

Publications (2)

Publication Number Publication Date
JP2022514835A true JP2022514835A (ja) 2022-02-16
JP2022514835A5 JP2022514835A5 (https=) 2023-01-06

Family

ID=71102651

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021534266A Pending JP2022514835A (ja) 2018-12-21 2019-12-23 インスリン及びグルカゴンを含む薬学組成物
JP2024147410A Pending JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024147410A Pending JP2024178193A (ja) 2018-12-21 2024-08-29 インスリン及びグルカゴンを含む薬学組成物

Country Status (10)

Country Link
US (1) US20220064248A1 (https=)
EP (1) EP3900734A4 (https=)
JP (2) JP2022514835A (https=)
KR (1) KR20200078414A (https=)
CN (1) CN113365651A (https=)
AU (1) AU2019405389B2 (https=)
BR (1) BR112021011557A2 (https=)
CA (1) CA3124340A1 (https=)
MX (1) MX2021007124A (https=)
WO (1) WO2020130751A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113453703A (zh) * 2018-12-21 2021-09-28 韩美药品株式会社 包括胰岛素和对胰高血糖素和glp-1和gip受体均具有活性的三重激动剂的药物组合物
EP4183407A4 (en) * 2020-07-15 2024-08-14 Hanmi Pharm. Co., Ltd. THERAPEUTIC USE OF A GLUCAGNONE DERIVATIVE OR CONJUGATE THEREOF FOR LIVER DISEASES

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514990A (ja) * 2002-12-27 2006-05-18 ディオベックス， インコーポレイテッド インスリン誘発性低血糖の予防および制御のための組成物および方法
WO2018004283A2 (ko) * 2016-06-29 2018-01-04 한미약품 주식회사 글루카곤 유도체, 이의 결합체, 및 이를 포함하는 조성물, 및 이의 치료적 용도
WO2018144867A1 (en) * 2017-02-03 2018-08-09 Vanderbilt University Systems, compositions and methods for treating diabetes
JP2018528234A (ja) * 2015-09-24 2018-09-27 ハンミ ファーマシューティカル カンパニー リミテッド 免疫グロブリン断片の特定位置を連結部位として用いたタンパク質結合体
JP2018531237A (ja) * 2015-09-25 2018-10-25 ハンミ ファーマシューティカル カンパニー リミテッド 多数の生理活性ポリペプチド及び免疫グロブリンＦｃ領域を含む、タンパク質結合体

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
JP4046354B2 (ja) 1996-03-18 2008-02-13 ボード オブ リージェンツ，ザ ユニバーシティ オブ テキサス システム 増大した半減期を有する免疫グロブリン様ドメイン
AR081066A1 (es) * 2010-04-02 2012-06-06 Hanmi Holdings Co Ltd Conjugado de insulina donde se usa un fragmento de inmunoglobulina
KR20140043709A (ko) * 2011-01-20 2014-04-10 질랜드 파마 에이/에스 아실화 글루카곤 유사체와 인슐린 유사체의 조합
DK2963056T3 (da) 2013-02-26 2020-02-17 Hanmi Pharm Ind Co Ltd Insulinanalog og anvendelse deraf
AR100695A1 (es) * 2014-05-30 2016-10-26 Hanmi Pharm Ind Co Ltd Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón
WO2015189698A2 (en) 2014-06-08 2015-12-17 Beijing Cosci-Remd Bio Med Tech Company Ltd Methods for treating type 1 diabetes using glucagon receptor antagonistic antibodies
PE20171154A1 (es) * 2014-12-30 2017-08-16 Hanmi Pharm Ind Co Ltd Derivados de glucagon con estabilidad mejorada
EP4523705A3 (en) * 2015-06-30 2025-06-11 Hanmi Pharm. Co., Ltd. Glucagon derivative and a composition comprising a long acting conjugate of the same
UY36870A (es) 2015-08-28 2017-03-31 Hanmi Pharm Ind Co Ltd Análogos de insulina novedosos
CN110545849A (zh) * 2017-02-03 2019-12-06 韩美药品株式会社 具有增加的持续性的生理活性物质的缀合物及其应用
GB201710822D0 (en) * 2017-07-05 2017-08-16 Zealand Pharma As Methods and medical uses relating to the treatment of hypoglycaemia

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514990A (ja) * 2002-12-27 2006-05-18 ディオベックス， インコーポレイテッド インスリン誘発性低血糖の予防および制御のための組成物および方法
JP2018528234A (ja) * 2015-09-24 2018-09-27 ハンミ ファーマシューティカル カンパニー リミテッド 免疫グロブリン断片の特定位置を連結部位として用いたタンパク質結合体
JP2018531237A (ja) * 2015-09-25 2018-10-25 ハンミ ファーマシューティカル カンパニー リミテッド 多数の生理活性ポリペプチド及び免疫グロブリンＦｃ領域を含む、タンパク質結合体
WO2018004283A2 (ko) * 2016-06-29 2018-01-04 한미약품 주식회사 글루카곤 유도체, 이의 결합체, 및 이를 포함하는 조성물, 및 이의 치료적 용도
WO2018144867A1 (en) * 2017-02-03 2018-08-09 Vanderbilt University Systems, compositions and methods for treating diabetes

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BIODRUGS, vol. 29, JPN6024043741, 2015, pages 215 - 239, ISSN: 0005446103 *
MED. CHEM. COMMUN., vol. 1, JPN6024043740, 2010, pages 319 - 324, ISSN: 0005446102 *

Also Published As

Publication number Publication date
WO2020130751A1 (ko) 2020-06-25
CN113365651A (zh) 2021-09-07
AU2019405389A1 (en) 2021-06-24
US20220064248A1 (en) 2022-03-03
MX2021007124A (es) 2021-08-11
EP3900734A1 (en) 2021-10-27
JP2024178193A (ja) 2024-12-24
CA3124340A1 (en) 2020-06-25
AU2019405389B2 (en) 2025-06-05
EP3900734A4 (en) 2022-10-12
BR112021011557A2 (pt) 2021-09-14
KR20200078414A (ko) 2020-07-01

Similar Documents

Publication Publication Date Title
AU2020277290B2 (en) Composition for treating diabetes mellitus comprising insulin and a GLP-1/glucagon dual agonist
JP7596268B2 (ja) グルカゴン、ｇｌｐ－１及びｇｉｐ受容体の全てに活性を有する三重活性体と、インスリンとを含む薬学組成物
JP6712322B2 (ja) グルカゴン、ｇｌｐ−１及びｇｉｐ受容体のすべてに活性を有する三重活性体の持続型結合体
TWI621626B (zh) 新穎胰島素類似物及其用途
JP2017071609A (ja) オキシントモジュリンと免疫グロブリン断片とを含む結合体及びその用途
JP2024178193A (ja) インスリン及びグルカゴンを含む薬学組成物
JP2023024674A (ja) インスリン受容体との結合力が減少されたインスリンアナログの結合体及びその用途
RU2823246C2 (ru) Фармацевтическая композиция, содержащая инсулин и глюкагон
JP2024503242A (ja) 短腸症候群の予防又は治療のためのインスリン分泌ペプチドとｇｌｐ－２の併用療法
RU2779462C2 (ru) Комплекс аналога инсулина со сниженной аффинностью к инсулиновому рецептору и его применение
HK40060818A (en) Pharmaceutical composition comprising insulin and triple agonist having activity with respect to all of glucagon and glp-1 and gip receptor
HK40013258A (en) Insulin analog complex with reduced affinity for insulin receptor and use thereof

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221223

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20221223

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20231016

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240116

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20240501

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240829

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20240906

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20241101